BAYTRIL MAX 10% INJ CATTLE & PIGS 100ML

4.1 Target species Cattle, Pig 4.2 Indications for use, specifying the target species Cattle: For the treatment of respiratory tract infections caused by enrofloxacin-sensitive Histophilus somni, Mannheimia haemolytica, Pasteurella multocida and Mycoplasma spp. For the treatment of mastitis caused by enrofloxacin-sensitive E. coli. Pig: For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive Actinobacillus pleuropneumoniae, Pasteurella multocida and complicated by Haemophilus parasuis as a secondary pathogen in pigs. 4.3 Contraindications Do not use for prophylaxis. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.Do not use in known cases of resistance to other (fluoro)quinolones due to the potential for cross-resistance. Do not use in animals with central nervous system-associated seizure disorders. Do not use in the presence of existing disorders of cartilage development or musculoskeletal damage around functionally significant or weight-bearing joints. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals For repeated injection or for injection volumes exceeding 15 ml (cattle) or 7.5 ml (pigs, calves) in divided doses, a new site must be chosen for each injection. Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Enrofloxacin is eliminated renally. As with all fluoroquinolones, delayed excretion can therefore be expected in the presence of existing renal damage. Special precautions to be taken by the person administering the veterinary medicinal product to animals Direct contact with the skin should be avoided due to sensitisation, contact dermatitis and possible hypersensitivity reactions. People with known hypersensitivity to (fluoro)quinolones should avoid contact with the product. Wash hands after use. In the event of accidental splash into the eye, rinse with large amounts of clean water. If irritation occurs, seek medical advice. Do not eat, drink or smoke while handling the product. Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician. 4.6 Adverse reactions (frequency and seriousness) In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the injection site. These regress within a few days without further therapeutic measures. In rare cases, intravenous treatment can cause shock reactions in cattle, probably as a result of circulatory disturbances. Gastrointestinal disturbances may occur in isolated cases during treatment of calves. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 4.7 Use during pregnancy, lactation or lay May be used during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction Antagonist effects due to concurrent administration of macrolides and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.
Vat Rate: 20%